Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Cluster randomised trial comparing outcomes of early psychosis care by a specialist team and augmented community mental health teams (CMHTs)

Acronym

SATS

Study hypothesis

That the provision of services by specialist teams for people experiencing a first psychotic episode confers no advantage over the provision of services for first episode psychosis provided by augmented non-specialist teams

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

First episode psychosis

Intervention

1. Specialist Early Intervention Service - a dedicated team specialising solely in the care of first episode psychosis. The team is multiprofessional and community based, has appropriate inpatient services and would be expected to maintain contact with all first episode patients for a period of 3 years.2. Augmented community mental health teams. These community based multiprofessional teams provide general mental health services to defined geographical catchment areas. For the purpose of the trial the service will be augmented by two whole time equivalent staff who will focus solely on the care of first episode psychosis and will be expected to maintain contact with patients for a three year period.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Proportion relapsing within 2 years of entry into the trial

Secondary outcome measures

1. Time to relapse2. Whether engaged in paid employment or education for at least 15 hours per week3. Quality of Life (MECCA)

Overall trial start date

31/01/2005

Overall trial end date

31/01/2008

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All patients with a first psychotic episode aged between 18 and 34 referred to augmented and specialist services who are resident in the catchment area of the services

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250

Participant exclusion criteria

People will not be accepted for assessment if:1. Their symptoms appear secondary to a primary diagnosis of emotionally unstable personality disorder or post-traumatic stress disorder2. Their symptoms appear to be the clear result of drug induced psychosis, narrowly defined. Psychosis will only be viewed as drug induced if symptoms have emerged suddenly in the context of intoxication without any previous decline in functioning and if they subside within a few days3. They have elevated mood but no psychotic symptoms4. Their psychotic symptoms are not associated with any decline in functioning, disruption of development, distress or risk5. They are thought to have taken antipsychotic medication for at least 6 weeks6. They were first diagnosed as having a psychotic illness by a specialist mental health service more than 1 year ago